Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

Phase 1

Terminated

• Conditions: Leukemia, Myelocytic, Acute
• Interventions: Procedure: Apheresis; Biological: Stem Cell Transplant

• Registration Number: NCT00048100
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

Objectives:

1. Determine the toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.

2. Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in patients after infusion.

3. Assess efficacy of acute myelogenous leukemia (AML) or Chronic Myelogenous Leukemia in Blastic Crisis (CML-BC) derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with relapse after allo-BMT or stem cell transplant.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2002-10-24
• Study First Submitted QC: 2002-10-24
• Study First Posted: 2002-10-25
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• AML (any type except M3) or CIVIL in blast crisis with greater than or equal to 20% bone marrow blasts at the time of related donor marrow or stem cell transplantation or at relapse post transplant.
• Willing to undergo a skin biopsy and either a leukodepletion apheresis or an additional marrow aspiration.
• Stem cell or marrow donor willing to have apheresis for T-Cell collection.
• Written voluntary informed consent must be obtained from patient and donor.

Exclusion Criteria

• Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
• AML French-American-British (FAB) subtype M3.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apheresis + Transplant	Stem Cell Transplant	Skin biopsy \& either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.
Apheresis + Transplant	Apheresis	Skin biopsy \& either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.

Primary Outcome Measures

Name	Time	Method
Participant Toxicity Levels	From stem cell transplant baseline to 30 plus days post transplant.	Participant toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.

Trial Locations

Locations (1)

M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States